Clinical Research Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Take on primary responsibility for designated clinical research projects, ensuring adherence to relevant regulations, guidelines, and corporate policies governing study activities.

• Oversee and implement the entire project scope, budget, and timelines.

• Determine project success criteria for analysis, reporting, and tracking purposes.

• Manage resources and timelines related to all study initiation and execution activities.

• Lead the creation of study-specific protocols, consent forms, and other necessary trial-related materials.

• Ensure the proper development of study documents, including but not limited to study plans, case report form guidelines, site selection materials, investigator updates, and other project-specific documents essential for conducting assigned studies.

• Engage in the review of clinical data for analytical purposes.

• Ensure that all project tasks align with client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).

• Act as a liaison between clients and internal teams to ensure timely communication of project-specific information and updates.

• Organize and manage all materials needed for the effective execution of clinical projects, including but not limited to the distribution of documents, forms, supplies, equipment, and investigational devices.

• Monitor compliance with project contracts and budgetary constraints.

• Collaborate with clinical, business development, and operations management to define goals and scope for clinical study projects.

• Ensure operational and regulatory compliance for assigned studies and participate in FDA or other regulatory inspections as required.

• Assist in the management and oversight of clinical study-related vendors.

• Review site monitoring reports, ensuring they are finalized according to SOP and/or client contractual obligations.

• Enhance the department and organization's reputation by participating in departmental or corporate initiatives.

• Update job knowledge through educational opportunities, reading professional literature, maintaining personal networks, and engaging in professional organizations.

• Attend off-site meetings and conferences as necessary.

⛳️ Requirements

• A Bachelor’s degree or equivalent education/degree in life sciences or healthcare is required, along with 5 years of experience in clinical research at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.

• Experience in a CRO is highly desirable.

• Preference for candidates with experience managing external vendors.

• Preferred experience includes leading project operational teams through the start-up, study conduct, data management, and report writing phases of clinical studies.

• Familiarity with writing, reviewing, and editing protocols and clinical study reports, as well as a working knowledge of the FDA submission process, is preferred.

🏝️ Benefits

• 100% Remote